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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 15181–15200 of 17,832 recalls

Class ITerminated

Burn 7 Capsules, supplied in 30 capsules bottle

Deseo Rebajar

Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement

December 23, 2013 · DrugView details →
Class IITerminated

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

Watson Laboratories, Inc.-(Actavis) - Florida

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

December 20, 2013 · DrugView details →
Class IITerminated

CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.

Carefusion 2200 Inc

Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.

December 20, 2013 · DrugView details →
Class IITerminated

CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18

Carefusion 2200 Inc

Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.

December 20, 2013 · DrugView details →
Class ITerminated

MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX

Abrams Royal Pharamacy

Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis

December 19, 2013 · DrugView details →
Class IITerminated

All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX

Abrams Royal Pharamacy

Lack of Assurance of Sterility

December 19, 2013 · DrugView details →
Class IITerminated

Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister).

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.

December 18, 2013 · DrugView details →
Class IITerminated

Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single blister).

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.

December 18, 2013 · DrugView details →
Class IIITerminated

Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).

Qualitest Pharmaceuticals

Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.

December 16, 2013 · DrugView details →
Class IIITerminated

VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.

Bracco Diagnostics Inc

Failed Stability Testing: This product is below specification for preservative content.

December 16, 2013 · DrugView details →
Class IITerminated

Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-01

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specification; 12-Month stability interval.

December 13, 2013 · DrugView details →
Class IITerminated

Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10

Corepharma LLC

Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.

December 13, 2013 · DrugView details →
Class IITerminated

Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Hospira Inc.

Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.

December 12, 2013 · DrugView details →
Class IITerminated

Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Zions RX Formulations Services LLC dba RX Formuations Serv.

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

December 12, 2013 · DrugView details →
Class IITerminated

Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Zions RX Formulations Services LLC dba RX Formuations Serv.

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

December 12, 2013 · DrugView details →
Class IITerminated

Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Zions RX Formulations Services LLC dba RX Formuations Serv.

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

December 12, 2013 · DrugView details →
Class IITerminated

Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Zions RX Formulations Services LLC dba RX Formuations Serv.

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

December 12, 2013 · DrugView details →
Class ITerminated

Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205.

Zions RX Formulations Services LLC dba RX Formuations Serv.

Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.

December 12, 2013 · DrugView details →
Class IITerminated

Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Zions RX Formulations Services LLC dba RX Formuations Serv.

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

December 12, 2013 · DrugView details →
Class IITerminated

Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Zions RX Formulations Services LLC dba RX Formuations Serv.

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

December 12, 2013 · DrugView details →
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